Back to resultsEfficacy of Chlorexidine as Intracanal Medicament in Primary Teeth
Primary Purpose
Dental Pulp Necrosis
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
chlorexidine
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Necrosis focused on measuring primary teeth, chlorexidine, root canal therapy, Pulpectomy
Eligibility Criteria
Inclusion Criteria:
- Healthy children of both gender;
- Without history of reactions or alergical diseases;
- With situated age between 04 and 08 years of age
- With normal standard of growth and development
- Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches.
Exclusion Criteria:
- Patients with history of alergical diseases
- Patients with allergy to any type of medicine and/or foods
- Patients with comprometimento of its general state of health
- Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses
- Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment
- With periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated
- Patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion
- Patients whose legal responsible or parents to refuse to sign the term of free and clarified assent
Sites / Locations
- Ramille Araújo Lima
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00624572
First Posted
February 15, 2008
Last Updated
February 25, 2008
Sponsor
Universidade Federal do Ceara
1. Study Identification
Unique Protocol Identification Number
NCT00624572
Brief Title
Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth
Official Title
Efficacy of 1% Chlorexidine Gel as Intracanal Medicament in Primary Molar Teeth - a Clinical and Microbiological Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal do Ceara
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Necrosis
Keywords
primary teeth, chlorexidine, root canal therapy, Pulpectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chlorexidine
Intervention Description
Chlorexidine gel 1% during 7 days inside root canals
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy children of both gender;
Without history of reactions or alergical diseases;
With situated age between 04 and 08 years of age
With normal standard of growth and development
Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches.
Exclusion Criteria:
Patients with history of alergical diseases
Patients with allergy to any type of medicine and/or foods
Patients with comprometimento of its general state of health
Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses
Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment
With periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated
Patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion
Patients whose legal responsible or parents to refuse to sign the term of free and clarified assent
Facility Information:
Facility Name
Ramille Araújo Lima
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60440-810
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth
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